Senior Submissions Officer

Job not on LinkedIn

🕒 August 5

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Support clients in all aspects of safety submissions • Support the Submission Manager with development, documentation, implementation, and maintenance of submission processes and standards • Maintain knowledge of global regulatory reporting requirements to ensure compliance • Perform submissions of ICSRs and aggregate reports to concerned parties • Perform ICSR exchanges with concerned parties according to applicable documents • Provide support for pharmacovigilance operations associated with safety reporting • Perform quality control of ICSR reportability assessments • Perform quality control of daily safety submission activities • Participate in training and maintain and develop quality system documents for the Safety Reporting area • Train junior team members • Act as a submissions subject matter expert during audits and inspections, representing submissions business processes and standards

🎯 Requirements

• Life science graduate, pharmacy, nursing, or other healthcare-related qualification • 3–5 years of work experience in pharmacovigilance • At least 2 years of experience working on submissions • Organizational skills, including attention to detail and multitasking • Management skills, including time and issue management • Communication skills, including clear and effective interaction with internal and external stakeholders • Fluent English, spoken and written

🏖️ Benefits

• Remote work option • Flexible work environment • Growth opportunities • Collaborative and supportive team culture • Training opportunities • Belonging-focused workplace • Opportunity to contribute to patient safety and global pharmaceutical treatments